Recall Z-1515-2021— Smiths Medical ASD Inc.
Class II · Terminated
Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2021-03-31, terminated 2023-01-31. It names one FDA 510(k) clearance: K812166. Product: Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.. Reason: The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels..
- Recalling firm
- Smiths Medical ASD Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-31
- Terminated
- 2023-01-31
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Palm Cups - Product Usage: intended to be used to percuss the chest wall to mobilize the secretions within the bronchial tree.
Reason for recall
The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.
Data sourced from openFDA. This site is unofficial and independent of the FDA.